Lincomycin hydrochloride
Standard of inspection items [Chinese Veterinary Pharmacopoeia (2015 edition)]
Properties This product is white crystalline powder; Slight odor or special odor. This product is soluble in water or methanol, slightly soluble in ethanol.
The spectra of infrared light absorption should be consistent with that of lincomycin reference.
In the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be the same as that of the control solution.
Identification of phchlorides in aqueous solution of the sample.
Moisture 3.0 ~ 6.0%
Acidity 3.0 to 5.5
Clarification degree and color of solution solution should be clarified; If the turbidity is obvious, it is not thicker than the standard liquid containing the same amount of turbidity No. 1. If the color is developed, it shall not be darker than the yellow or yellow-green standard colorimetric solution No. 1 containing the same amount.
Incense burning residue ≤0.5%
Lincomycin B≤5.0%
Content ≥82.5% (dry product)
Crystallization The crystal optical phenomena of birefringence and extinction potential appear when the stage is rotated.
Bacterial endotoxin < 0.50EU/mg (for injection).
Except for lincomycin B, the area of a single impurity peak should not be greater than the area of the main peak of the reference solution (1.0%), and the sum of the areas of each impurity peak should not be greater than 2 times the area of the main peak of the reference solution (2.0%). Any peak in the chromatogram of the solution of the test product that is less than 0.05 times the area of the main peak of the reference solution can be ignored.